MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number MAJ-2111

Device Problems Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer returned the device as the device cracked and would not seal onto the automatic endoscopy reprocessor.There is no patient involvement.

Manufacturer Narrative

Customer reported two events of failed connecting tube devices of different model numbers for the oer-elite automatic endoscopy reprocessor (aer).These events are captured in medwatches with patient identifiers (b)(6) (for air/water channel) and (b)(6) (for instrument channel).This medwatch is for the patient identifier (b)(6).The device is returned, and an evaluation completed for it.The device was returned in its original packaging.A visual inspection on the device in as received condition was performed.The inspection of the connecting tube started from the slide adaptor section and scratches on stainless-steel were observed.Additionally, the reprocessor connector of the connecting tube was also inspected to verify its condition.Once inspected, it was noted that there were no cracks, break, rip, scratches, attached debris or other irregularities.The user¿s complaint of not sealing onto the oer-elite could not be confirmed or replicated as no oer-elite test device was available for testing.The user¿s complaint of cracks was not confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, there is a possibility that foreign material got caught between the connector of the connecting tube and the connector in the reprocessing basin.A specific cause for the foreign material could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: CONNECTING TUBE
• Type of Device: ENDOSCOPE REPROCESSOR ACCESSORIES
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16064843
• MDR Text Key: 308478803
• Report Number: 9610595-2022-06228
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2111
• Device Lot Number: 28A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OER-ELITE.